2. Clinicians Involved in Screening, Evaluation, and Treatment of HIV/AIDS, Hepatitis C Viral Infection, and Sexually Transmitted Infections in Substance Abuse Treatment Programs: the National Drug Abuse Treatment Clinical Trials Network L.S. Brown, MD, MPH; S. Kritz, MD; J. Rotrosen, MD; R.J. Goldsmith, MD; E. Bini, MD, MPH; J. Robinson, MEd, and the NIDA Clinical Trials Network Infections Study (CTN-0012) Team Poster Presentation at the Annual Meeting of the American Society on Addiction Medicine, San Diego, CA – May 5, 2006

3. ABSTRACT ABSTRACT In the US, users of illicit drugs will largely sustain the epidemics of HIV/AIDS, hepatitis C (HCV), and sexually transmitted infections (STI). Substance abuse treatment programs can play a major role in stemming these epidemics. A nationwide study, sponsored by the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) examines these three infection groups from the perspective of administrators and clinicians working in substance abuse treatment programs, and the states within which they are located. The NIDA CTN has over 100 Community Treatment Programs (CTPs) with over 300 discreet substance abuse treatment sites in 17 nodes across the US. Three surveys were developed; one each for substance abuse treatment program administrators and clinicians, and one for state health and substance abuse department administrators. This report examines HIV/AIDS, HCV, and STI-related services provided by substance abuse treatment programs in the NIDA CTN from the perspective of the clinicians, medical and non-medical, expert and non-expert, working in these programs. The clinician survey looked at practices, program guidelines, knowledge, barriers, and opinions of clinicians caring for substance abusers within their program. Completed surveys were obtained from 1719 of 2207 targeted clinicians working at 265 substance abuse treatment sites. The breakdown of completed surveys was: (1) medical expert: 251; (2) medical non-expert: 115; (3) non-medical expert: 522; and (4) non- medical non-expert: 831. The extensive data obtained from this group of clinicians will be presented to inform public policy to encourage “best practices” in treating these epidemic infections.

4. ACKNOWLEDGEMENTS Research Supported by National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) with the NIDA CTN and other Protocol Team members consisting of: Research Supported by National Institute on Drug Abuse (NIDA) as part of a Cooperative Agreement (1U10DA013046) with the NIDA CTN and other Protocol Team members consisting of: –Randy Seewald, MD; Cheryl Smith, MD; Frank McCorry, PhD; Dennis McCarty, PhD; Donald Calsyn, PhD; Leonard Handelsman, MD; Steve Kipnis, MD –Patrick McAuliffe, MBA, LADC; Al Hassen, MSW; Karen Reese, CAC-AD; Sherryl Baker, PhD –Shirley Irons; Kathlene Tracy, PhD

5. Drug Abuse Treatment Clinical Trials Network Philadelphia Portland Los Angeles Charleston Miami Cincinnati Denver CTN Sites Seattle Raleigh/ Durham Long Island Boston San Francisco (CA/AZ Node) New York City Detroit Albuquerque Baltimore/Richmond New Haven 17 Nodes with 116 Community Treatment Agencies Reaching into 26 States!

6. STUDY SITES STUDY SITES New York Node: New York University, New York, NY New York Node: New York University, New York, NY South Carolina Node: Medical University of South Carolina, Charleston, SC South Carolina Node: Medical University of South Carolina, Charleston, SC Florida Node: University of Miami, Coral Gables, FL Florida Node: University of Miami, Coral Gables, FL Great Lakes Node: Wayne State University, Detroit, MI Great Lakes Node: Wayne State University, Detroit, MI Ohio Valley Node: University of Cincinnati, Cincinnati, OH Ohio Valley Node: University of Cincinnati, Cincinnati, OH Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO Rocky Mountain Node: University of CO Health Sciences Center, Denver, CO New England Node: Yale University, New Haven, CT New England Node: Yale University, New Haven, CT Delaware Valley Node: University of Pennsylvania, Philadelphia, PA Delaware Valley Node: University of Pennsylvania, Philadelphia, PA Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College of Virginia, Richmond of Virginia, Richmond Pacific Region Node: University of California at Los Angeles, CA Pacific Region Node: University of California at Los Angeles, CA Oregon Node: Oregon Health Sciences University, Portland, OR Oregon Node: Oregon Health Sciences University, Portland, OR Washington Node: University of Washington, Seattle, WA Washington Node: University of Washington, Seattle, WA Long Island Node: NY State Psychiatric Institute, New York, NY Long Island Node: NY State Psychiatric Institute, New York, NY North Carolina Node: Duke University, Raleigh/Durham, NC North Carolina Node: Duke University, Raleigh/Durham, NC Southwest Node: University of New Mexico, Albuquerque, NM Southwest Node: University of New Mexico, Albuquerque, NM Northern New England Node: McLean Hospital, Belmont, MA Northern New England Node: McLean Hospital, Belmont, MA California-Arizona Node: University of California at San Francisco, CA California-Arizona Node: University of California at San Francisco, CA

7. STUDY RATIONALE STUDY RATIONALE HIV/HCV/STI: major causes of excess morbidity and mortality in the US HIV/HCV/STI: major causes of excess morbidity and mortality in the US Substance abuse: a major vehicle for the transmission of infection Substance abuse: a major vehicle for the transmission of infection Scope of, and challenges to identifying, counseling, and treating persons with these infections in substance abuse treatment will assist in developing effective interventions Scope of, and challenges to identifying, counseling, and treating persons with these infections in substance abuse treatment will assist in developing effective interventions

8. IMPORTANT ABREVIATIONS IMPORTANT ABREVIATIONS HIV = Human Immunodeficiency Virus HIV = Human Immunodeficiency Virus AIDS = Acquired Immunodeficiency Syndrome AIDS = Acquired Immunodeficiency Syndrome HCV = Hepatitis C Virus HCV = Hepatitis C Virus STI = Sexually Transmitted Infections STI = Sexually Transmitted Infections CTP = Community Treatment Program CTP = Community Treatment Program CTN = Clinical Trials Network CTN = Clinical Trials Network SOP = Standard Operating Procedures SOP = Standard Operating Procedures IRB = Institutional (Human Subject) Review Board IRB = Institutional (Human Subject) Review Board

9. IMPORTANT DEFINITIONS IMPORTANT DEFINITIONS Treatment Program vs. NIDA CTN CTP Treatment Program vs. NIDA CTN CTP Services Assessed Services Assessed –Provider Education –Patient Education –Patient Risk Assessment –Patient Counseling –Patient Medical History & Physical Exam –Patient Biological Testing –Patient Treatment –Patient Monitoring Medical vs. Non-Medical Clinical Staff Medical vs. Non-Medical Clinical Staff ‘Expert’ Clinical Staff ‘Expert’ Clinical Staff

10. PRIMARY OBJECTIVES TO DESCRIBE: TO DESCRIBE: –Range of Infection-Related Services Available –Clinician Characteristics (training, knowledge, behavior) –Opinions –Perceived Barriers to Providing Infection-Related Services TO EXAMINE ASSOCIATIONS BETWEEN: TO EXAMINE ASSOCIATIONS BETWEEN: –CTPs ’ Availability of Selected Infection Services –Other Constructs Listed Above

11. DESIGN AND POPULATION STUDY DESIGN STUDY DESIGN –Cross-sectional Survey –Descriptive & Exploratory STUDY POPULATION STUDY POPULATION –CTP Clinicians

12. ETHICAL, REGULATORY & ADMINISTRATIVE CONSIDERATIONS Expedited IRB Approval Expedited IRB Approval Waiver of Informed Consent Waiver of Informed Consent Training for Node Protocol Managers Training for Node Protocol Managers

13. STUDY PROCEDURES STUDY PROCEDURES Node Protocol Managers Node Protocol Managers Information Sheet In Lieu of Informed Consent Information Sheet In Lieu of Informed Consent Survey Administration Survey Administration – Paper or Electronic – Central data acquisition

14. Clinician Surveys Statistician selects Clinicians from Treatment Programs based on contact information provided by Administrators Clinician surveys mailed Gathering sessions held for Clinicians to complete surveys Clinician completes survey online or mails to Data Center Completed surveys mailed to Data Center Data Center contacts non- responders after 30 days; flagged as non-responders after four weekly failed attempts If non-responder is a randomly selected Clinician, the next eligible Clinician on the selection list is sent a survey Data Center monitors the data entry of Clinicians Data Center contacts Clinicians to resolve any data queries Randomization

15. MEASUREMENTS & ANALYTICAL METHODS SAMPLING METHODOLOGY: At Each CTP … SAMPLING METHODOLOGY: At Each CTP … – All ‘Expert’ Clinicians Designated by the CTP – 10 randomly sampled ‘Non-Expert’ Clinicians, in a ratio of Medical:Non-Medical reflecting that of in a ratio of Medical:Non-Medical reflecting that of the CTP’s clinical staff the CTP’s clinical staff ANALYTIC METHODOLOGIES ANALYTIC METHODOLOGIES – ‘Experts’ will be analyzed separately – Clinicians may decline; next randomly selected person will be asked to participate selected person will be asked to participate

16. STATISTICAL ELEMENTS Sample Size and Precision of the Estimated Mean Sample Size and Precision of the Estimated Mean Analytic Plan Analytic Plan –Descriptive stats for survey variables –Principal Component or Cluster or Factor Analysis to group and reduce the number of variables –Structural Equation Models to test for associations

17. RESULTS Surveys Obtained from 1719 Clinicians of 2207 Targeted (78%) Surveys Obtained from 1719 Clinicians of 2207 Targeted (78%) 831 Non-Medical Non-Experts (48%) 831 Non-Medical Non-Experts (48%) 115 Medical Non-Experts (7%) 115 Medical Non-Experts (7%) 522 Non-Medical Experts (30%) 522 Non-Medical Experts (30%) 251 Medical Experts (15%) 251 Medical Experts (15%)

18. HIV/AIDS, HCV & STI-RELATED SERVICES IN SUBSTANCE ABUSE TREATMENT PROGRAMS: NIDA CTN ADMINISTRATOR RESPONSES (N=269) HIV/AIDSHCVSTIs SERVICE n (%) Provider Education 186 (69) 171 (63) 155 (57) Patient Education 226 (84) 200 (74) 205 (76) Risk Assessment 224 (89) 194 (77) 195 (77) History & Physical Examination 150 (56) 135 (50) 133 (49) Testing 131 (49) 93 (34) 109 (40) Counseling 178 (66) 159 (59) 163 (60) Treatment 103 (38) 78 (29) 92 (34) Monitoring 117 (43) 95 (35) 105 (39)

19. CLARITY OF HIV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLEAR NON - EXPERT EXP EXPERT SERVICENon-MedMedicalNon-MedMedicalOVERALL Provider Education 50%55%56%49%52% Patient Education 57%60%66%54%60% Risk Assessment 57%54%65%59%60% History & Physical Exam 56%66%53%76%58% Testing35%47%42%59%41% Counseling49%52%54%58%52% Treatment43%55%46%55%47% Monitoring39%42%38%51%41%

20. CLARITY OF HCV GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLEAR NON - EXPERT EXP EXPERT SERVICENon-MedMedicalNon-MedMedicalOVERALL Provider Education 42%53%43%45%43% Patient Education 48%54%51%48%49% Risk Assessment 48%50%54%54%51% History & Physical Exam 53%64%50%74%56% Testing32%44%37%54%37% Counseling41%47%45%51%44% Treatment39%52%40%48%41% Monitoring35%42%32%43%36%

21. CLARITY OF STI GUIDELINES: % OF CLINICIANS SCORING GUIDELINES AS CLEAR NON - EXPERT EXP EXPERT SERVICENon-MedMedicalNon-MedMedicalOVERALL Provider Education 40%50%41%40%41% Patient Education 47%51%50%41%47% Risk Assessment 46%48%51%46%48% History & Physical Exam 49%64%49%73%53% Testing28%42%35%50%35% Counseling39%45%44%44%41% Treatment37%53%40%51%41% Monitoring32%42%31%43%34%

22. SUMMARY There is… There is… –substantial variation in the % of programs offering the various services for a particular infection group –consistency in the % of programs offering a particular service for all three infection groups

23. SUMMARY Clarity of guidelines for the 8 targeted services is generally about 50% or less for all three infection groups, with the following exceptions: Clarity of guidelines for the 8 targeted services is generally about 50% or less for all three infection groups, with the following exceptions: –History & Physical Exam (medical experts and non-experts) for all three infection groups –Patient Education and Risk Assessment (non- medical experts) for HIV

24. SUMMARY Significant opportunities exist to explore other associations between the HIV/AIDS, HCV & STI-related services offered and… Significant opportunities exist to explore other associations between the HIV/AIDS, HCV & STI-related services offered and… –Clinician Characteristics (training, knowledge, behavior) –Opinions –Perceived Barriers to Providing Infection- Related Services